1Complaint and recall handling
Complaint procedures are deficient in that they do not include provisions that allow for the review and determination of an investigation by the quality control unit.
Inspection Record
RC Outsourcing LLC — FDA 483 Findings
Inspectors Taichun QinThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
3Process validation
Written production and process control procedures are not followed in the execution of production and process control functions.
4Other quality system
Reserve drug product samples are not appropriately identified and representative of each lot or batch of drug product.
5Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that conform to appropriate standards of identity, strength, quality and purity.
6Laboratory and QC controls
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness and compliance with established standards.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
8Material and supplier control
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
About this record
Extracted automatically from the document US FDA published on 2024-12-12. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
